This study is an open, single-arm, prospective, Phase I/II clinical study using "3+3" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed/refractory malignant hematological neoplasms in subjects.
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Single group
CAR-T Cells infusion（CAR2219,CAR2019, CAR19 etc）
DrugPhase I study: dose-escalation component.This part follows the "3+3" dose-escalation model, with 5 dose groups: 1×10\^6, 1.5×10\^6, 2×10\^6, 2.5×10\^6, 3×10\^6 CAR+ cells/kg (different target CAR-T can be adjusted by the investigator according to the dose used in the previous clinical trial). Each dose group enrolled 3\~6 patients with relapsed/refractory hematological diseases respectively, totaling 15\~30 subjects, in order to evaluate the safety of CAR-T cells for the treatment of relapsed/refractory malignant hematological neoplasms and to determine the MTD. Phase II study: dose-expansion portion. After the MTD was confirmed, in the dose-expansion portion of the study (Phase II), it was expected that 65\~60 subjects would receive the CAR-T cell injection infusion under RP2D to further evaluate the efficacy of CAR-T cell injection.
The incidence of adverse events
Objective response rate (ORR)
Complete response rate (CRR)
Duration of response (DOR)
Progression free survival (PFS)
Kinetics of CAR-T cells
Use flow cytometry or Q-PCR to monitor the kinetics of CAR-T cells.
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Tianjin Medical University General Hospital
Lead sponsor
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator
